WHAT HAPPENS TO THE INFORMATION I PROVIDE AS PART OF THE STUDY?

All study data will be stored in a confidential data repository that meets the HIPAA security standards and stored in accordance with applicable local, state, and federal laws. Individual records will be assigned a confidential ID number and will be separated from your personally identifiable information (e.g., name, address, phone number). The Researchers will analyze only the encrypted data that does not identify you directly. The Sponsor may share this encrypted data with third party partners for future research, so long as such research partners legally agree to maintain the confidentiality of such information. The IRB will be informed of any data sharing agreements.  Study results presented at meetings and published in scientific journals and books will only be reported in aggregate form without identifying individual participants.

A National Institutes of Health (NIH) Certificate of Confidentiality (CoC) will further protect your confidential information from court subpoena except where required by law for child abuse, intent to hurt yourself or others, or in Food and Drug Administration (FDA) or other federal government audits. A CoC does not represent an endorsement of the research study by the Department of Health and Human Services or the NIH.